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Zavation recalls InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTV
Recalled June 9, 2021 · FDA recall Z-1751-2021 · Zavation
Hazard
Products distributed as sterile may not have been adequately sterilized · FDA Class II
Units
503 units
Sold at
US nationwide distribution.
Description
Products distributed as sterile may not have been adequately sterilized
Product
InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c) INTVM-15-DSK d) INTVM-15-DSKC e) INTVM-15-SBK f) INTVM-15-SIKBC g) INTVM-20-DSK h) INTVM-20-SBK. For use in Orthopedic / spinal procedures.
Manufacturer(s)
Zavation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →